๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-24

Study of GS-4528 in Adults With Solid Tumors (NCT05840224)

A Phase 1 Study to Evaluate the Safety and Tolerability of GS-4528 as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors

๐Ÿ”ต Active, Not Recruiting Phase1 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Gilead Sciences

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The goals of this clinical study are to identify if GS-4528 alone or in combination with anti-programmed cell death protein 1 (PD-1) (Anti-PD-1) Monoclonal Antibody is safe and tolerable in people with solid tumors and to identify the recommended dose of GS-4528 for further development that is safe to give to people alone or in combination with Anti-PD-1 Monoclonal Antibody. The primary objectives of this study are: * To assess the safety and tolerability of GS-4528 as monotherapy and in combination with Anti-PD-1 Monoclonal Antibody in participants with advanced solid tumors. * To identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and/or the recommended Phase 2 dose (RP2D) of GS-4528 as monotherapy and in combination with Anti-PD-1 Monoclonal Antibody in participants with advanced solid tumors.

Who can join: Review the eligibility criteria below.

Location: The University of Washington/FHCC โ€” Seattle, Washington

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (16 Sites)

  • The University of Washington/FHCC โ€” Seattle, Washington
  • The Ottawa Hospital โ€” Ottawa,
  • University Health Network, Princess Margaret Cancer Centre โ€” Toronto,
  • Asan Medical Center โ€” Seoul,
  • Severance Hospital, Yonsei University Health Systems โ€” Seoul,
  • Samsung Medical Center โ€” Seoul,
  • NEXT Oncology-Hospital Quironsalud Barcelona - Unidad de Ensayos Fase 1 โ€” Barcelona,
  • Hospital Universitari Vall D'Hebron- Oncology Service โ€” Barcelona,
  • START MADRID_Hospital Universitario Fundacion Jimenez Diaz - Unidad de Ensayos Fases I โ€” Madrid,
  • START MADRID_HM Sanchinarro-CIOCC-Unidad de Ensayos Fases I โ€” Madrid,
  • Clinica Universidad de Navarra- Unidad Central de Ensayos Clinicos โ€” Pamplona,
  • Taichung Veterans General Hospital โ€” Taichung,
  • National Taiwan University Hospital โ€” Taipei,
  • Chang Gung Memorial Hospital Linkuo Branch of the Chang Gung Medical Foundation โ€” Taoyuan,
  • St Bartholomew's Hospital โ€” London,
  • The Royal Marsden NHS Foundation Trust โ€” Sutton,

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Solid Tumor clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—